[Federal Register: November 3, 2003 (Volume 68, Number 212)]
[Notices]
[Page 62298-62299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no03-44]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998D-0896]
Guidance for Industry and Food and Drug Administration Staff;
Premarket Approval Application Modular Review; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Premarket Approval
Application Modular Review.'' This guidance document is intended to
provide industry and FDA staff with information regarding the premarket
approval application (PMA) modular review program. This guidance
document is immediately in effect, but it remains subject to comment in
accordance with the agency's good guidance practices (GGPs).
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Premarket Approval
Application Modular Review'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health (CDRH), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
labels to assist that office in processing your request, or fax your
request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document provides FDA's recommendations about the
content of a modular PMA and the procedures for submitting and
reviewing a modular PMA. This document supersedes and replaces the
guidance document entitled ``Guidance for the Medical Device Industry
on PMA Shell Development and Modular Review'' issued on November 6,
1998.
FDA is making this guidance effective immediately because there is
a statutory requirement that requires immediate implementation, and
guidance is needed to help effect such implementation. On October 26,
2002, the Medical Device User Fee and Modernization Act of 2002
(MDUFMA) was signed into law. Section 209 of MDUFMA amended section
515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)),
to codify FDA's modular review program for PMAs and authorize FDA to
assess user fees for modular PMAs. In developing this guidance, the
agency has considered its experience with its modular review program
and comments on the topic that were submitted to the public docket on
MDUFMA Implementation (Docket No. 02N-0534 (68 FR 5643, February 4,
2003)).
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs regulation
(21 CFR 10.115). The guidance represents the agency's current thinking
on modular PMAs. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collections of information addressed in the guidance document have
been approved by OMB in accordance with the PRA under the regulations
governing PMAs (21 CFR part 814, OMB control number 0910-0231).
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments on the guidance at any
time. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments.
Submit two paper copies of any mailed
comments, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. The guidance and comments received may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
To receive a copy of ``Premarket Approval Application Modular
Review'' by fax, call the CDRH Facts-On-Demand system at 800-899-0381
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt, press 1 to order a document. Enter
the document number (835) followed by the pound sign ([numsign]).
Follow the remaining voice prompts to complete your request.
[[Page 62299]]
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
Dated: October 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27561 Filed 10-31-03; 8:45 am]
BILLING CODE 4160-01-S